CN105147347A - Recovery catheter assembly - Google Patents

Abstract

An example of recovery catheter assembly comprises an actuator element (138) and a mechanically radially expandable and contractible recovery device (130) operably connected to the actuator element. The recovery device has proximal (131) and distal (132) blocking portions and a central portion therebetween. The recovery device is at least partially placeable in a first, radially collapsed configuration and in a second, radially expanded configuration by manipulation of the actuator element. When in the second, radially expanded configuration, the proximal and distal blocking portions have radial dimensions greater than the radial dimension of the central portion thereby at least partially defining a collection chamber at the central portion.

Description

Reclaim catheter kit

The divisional application that the application is the applying date is on March 4th, 2011, application number is 201180022704.3, denomination of invention is the application for a patent for invention of " recovery catheter kit ".

Invention field

The present invention relates to the system and method for the local organ perfusion of tumor or other serious conditions, it uses one or more high-dose therapy material, isolates, collects, filters and returned human body to Venous flow effluent after removing high-dose therapy material.

Background technology

There is the method for several treatment cancerous tumour, comprise operation, chemotherapy, the local ablation by the various forms of energy of conveying, radiation, etc.Usually, tumor is because diffused into surrounding tissue or remote organization's (such as liver, lung or brain) can not pass through excision.When only having minority focus, with chemotherapy, local operation excision and local ablation, the treatment of metastatic disease being carried out to these organs, using radiation once in a while.Usually, described metastatic disease is diffusion and is unsuitable for operation, radiation or local ablation.This makes chemotherapy as unique selection, and the effect of chemotherapy is limited to the systemic toxicity that medicine causes, comprise bone marrow depression, neutrophilic granulocytopenia, feel sick, diarrhoea, anorexia, become thin, cachexia, antibacterial or virus undue growth etc.

In U.S. Patent number 5069662, describe system, process and the method with the unusual organ isolated organ perfusion of the chemotherapeutics of high dose by Glickman at U.S. Patent number 5817046,5893841,5897533,5919163 and 7022097 and by Bodden, collect from this organ before entering systemic circulation and flow out venous blood, from chemotherapeutics described in collected blood filtration, and the filtering blood returned without chemotherapeutics is to systemic circulation.This system is sold by Delcath, Inc (NewYork, NY) at present, as be used for the treatment of Metastatic Liver disease and primary tumor object through skin liver perfusion (PHP) equipment.It is that the chemotherapeutics of unusual high dose is injected Hepatic artery a period of time, usually from 30 minutes to 1 hour in essence.High dose chemotherapy agent perfusion liver and traditional whole-body dose of using than intravenous is more effective.This medicine is absorbed by tumor, remaining inflow hepatic vein (a series of vein entering postcava (IVC) from liver).By collecting the blood of the chemotherapeutics containing toxic level as the spacer assembly of this special installation (PHP) part.Hepatic vein blood spacer assembly is the double bolloon system applied in postcava, air bag described in inflation above and below hepatic venous, the filter pump collected also through removing chemotherapeutics in hepatic venous effluence to conduit is outside to human body, and returns superior vena cava by another conduit.There is provided by returning tube chamber (also referred to as Returning pipe) to allow the blood in postcava to flow back into heart from lower limb and kidney when the inaccessible caval vein of described air bag.

Although current prior art equipment is effective in treatment tumor or liver neoplasm, but using is that some is troublesome, because described double bolloon may block kidney and/or adrenal veins, and described air bag tends to take more postcava space than desired.And, the volume enough not returned the blood of heart by tube chamber even as big as accommodation from lower postcava pumping blood to heart.This often causes the unexpected decline of patients' blood, and causes the situation of similar shock once in a while.Because expection patient can need recovery to a certain degree, therefore need anaesthetist to show up and process these problems.Significantly, because these problems of prior art, the significant cost ground of the risk sum of patient increases.This is serious problem, is not only because the risk to patient, and because it may stop intervention doctor to be patient and recommend their doctor physician to carry out this therapeutic strategy.These problems that prior-art devices and technology exist may hinder this very effective therapy system to be adopted fully by medical circle, thus deprive thousands of patient and be benefited from treatment.Exist because of potential malignant tumor in injured patient by these Iatrogenic Complications (as kidney and adrenal veins thrombosis, the instability perfusion of the heart, brain and kidney, cause heart attack, apoplexy, other complication such as kidney damage) prominent question that causes.These complication use obturation, change, the redirected early stage airbag technology of blood in human body in stream and the result of method.

The size of the air bag restricted passage tube chamber of prior-art devices, because the air bag expanded must occupy most of postcava effectively to isolate hepatic vein.Which has limited the blood flow volume that can return right atrium from postcava, cause the problem mentioned in the preceding paragraph falls.The taking up room of air bag (particularly afterbody air bag) of expanding in postcava is problematic, because more leaning on the distance between the hepatic vein of afterbody and kidney/adrenal veins to be usually be less than taking up room of described swelling gasbag.

Have viewed in a series of CT scan more than 50 abdominal paries, the present inventor by from joint portion, caval vein atrium (cavoatrialjunction) to the measurement in renal veins hole, left side, determines that the current prior-art devices of Glickman may partly inaccessible left side renal veins in the case being greater than 1/3.If measure inexactness to curvature and other to use the compensating factor of 15mm, then still have left side renal veins in the case being greater than 20% by least in part by situation that the afterbody air bag of current device covers.

And, the equipment of different-diameter may be needed, because the front and back (AP) of IVC and the measurement of horizontal size show huge difference in those measurements.After top IVC, middle part liver IVC and immediately before the average A P of renal veins IVC and lateral dimension be respectively 23.6mm and 30.4mm, 20.0mm and 22.7mm and 20.2mm and 28.3mm.In an object, existence only has the minimum AP size of 8mm and in another object, there is the maximum AP size of 36mm.Lateral dimension in different object from 10.2mm to 40mm not etc.The measurement taked may not be suitable for not agnate crowd, and may be more different in different crowd and age group.And in same patient, repeatedly IVC to measure on the large oval diaphragm of display the IVC of the elliptical configuration of the inclination after IVC, less round middle part liver directly over IVC and renal veins.In fact, the incline direction of the elliptical configuration of the inclination directly over renal veins is often contrary with the elliptical configuration of the inclination of IVC on diaphragm.

Summary of the invention

Embodiments of the invention successfully and effectively can collect hepatic venous effluence, and it is not had from systemic circulation isolation the problem that current double bolloon system causes.According to some embodiments, realizing isolation when not blocking adrenal veins or renal veins, providing when not using air bag large pipeline to make blood flow to heart from postcava without barrier simultaneously.

The first embodiment reclaiming catheter kit comprises actuator element and may be operably coupled to the radial inflatable and contractile retracting device of machinery of actuator element.Described retracting device has near-end and distal tip and comprises the blocking part of near-end and far-end at its near-end and far-end.Described retracting device also has middle body between near-end and far-end blocking part.By operating described actuator element, described retracting device can be placed at least in part the first radial collapse configuration and the second expanded radially configuration.When being placed in the second expanded radially configuration, described near-end and far-end blocking part have the radial dimension being greater than middle body radial dimension, thus limit collecting chamber at least in part in central part office.In certain embodiments, by operating described actuator element, described retracting device can be placed in completely the first radial collapse configuration and the second expanded radially configuration.In certain embodiments, the annular that described retracting device comprises near-end and far-end in near-end and the distal tip of retracting device blocks air bag.Some embodiments comprise there is sidewall and limit reclaim tube chamber hollow reclaim conduit.Some embodiments can also comprise the side passageway extended via the middle body of described retracting device and the sidewall of described recovery conduit, except described passage, the part of the described near-end and far-end blocking part and middle body that limit described collecting chamber is at least in part that liquid is impermeable, and the liquid wherein in collecting chamber can be entered by described passage and pass through to reclaim tube chamber.In certain embodiments, reclaim conduit and comprise near-end, centre and distal portions, described side passageway is located along the mid portion of described recovery conduit, blood pump is located along the distal portions of described recovery conduit, and filter cell is located along the distal portions of described recovery conduit, for from flow through reclaim catheter lumen fluid in filter at least one material.In certain embodiments, first pressure transducer is in described collecting chamber, second pressure transducer is positioned at the far-end of described retracting device, filter cell and pump are operationally coupled to described recovery conduit with pumping fluid by reclaiming conduit and being filtered through the fluid reclaiming conduit, and pump is operationally coupled to the first and second pressure transducers, to allow the pressure in use controlled in collecting chamber.In certain embodiments, filter cell and pump are operationally coupled to described recovery conduit with pumping fluid by reclaiming conduit and being filtered through the fluid reclaiming conduit, pressure transducer is positioned at the near-end of described pump, and described pump is operationally coupled to described pressure transducer to allow the pressure in use controlled in collecting chamber.In some instances, described actuator element comprises the first and second actuator element, and described retracting device comprises the proximal end that may be operably coupled to the first actuator element and the distal tip that may be operably coupled to the second actuator element; By operating described first and second actuator element, described retracting device can be placed in the first radial collapse configuration and the second expanded radially configuration at least in part.

Reclaim second embodiment of catheter kit, use for the opening part in body passages, comprise the outer actuator sleeve pipe with distal portions and the recovery of the inner hollow with sidewall conduit.Described recovery conduit limits and reclaims tube chamber and have distal tip.Described recovery conduit is positioned at described actuator sleeve pipe.Actuator wires extends along described recovery conduit and has the tip of the far-end being positioned described recovery distal end of catheter end.The radial inflatable and contractile retracting device of machinery is had and is fixed to the proximal end of actuator boot distal portion by proximal extension element and is fixed to the distal tip at described actuator wires tip by remote extension element.Described retracting device comprises near-end and far-end blocking part at its near-end and distal tip, the middle body between described near-end and far-end blocking part, and extend between described near-end and distal tip return tube chamber.When relative to described retracting device, described actuator wires being distally pushed into the position of far-end actuator wires, and when described actuator sleeve pipe being proximally pulled to the position of near-end actuator sleeve pipe relative to described retracting device, described retracting device can be placed in the first radial collapse configuration.When relative to described retracting device, described actuator wires being proximally pulled to the position of near-end actuator wires, and when described actuator sleeve pipe being distally pushed into the position of far-end actuator sleeve pipe relative to described retracting device, described retracting device can be placed in the second expanded radially configuration.When the second expanded radially configuration, described near-end and far-end blocking part have the radial dimension that is greater than described middle body radial dimension thus collecting chamber are limited to middle body, and described near-end and far-end expansion element have open area with what allow fluid to flow through described retracting device returns tube chamber.Side passageway extends via the middle body of described retracting device and the sidewall of described recovery conduit.Except described passage, the part of the described near-end and far-end blocking part and middle body that limit described collecting chamber is that liquid is impermeable, and the liquid thus from the opening of the fluid handling pipe opened to described collecting chamber can be entered and by described recovery tube chamber by described passage.

Reclaim the 3rd embodiment of catheter kit, use for the opening part in body passages, comprise the outer actuator sleeve pipe with distal portions and the recovery of the inner hollow with sidewall conduit.Described recovery conduit limits and reclaims tube chamber and distal tip.Described recovery conduit is positioned at described actuator sleeve pipe.Described recovery conduit has and to extend and tip is positioned the actuator wires of the far-end of described recovery distal end of catheter end along described recovery conduit.The radial inflatable and contractile retracting device of machinery is had and is fixed to the proximal end of actuator boot distal portion by proximal extension element and is fixed to the distal tip at described actuator wires tip by remote extension element.Described retracting device comprises near-end and distal annular rim at its near-end and distal tip and blocks air bag, the middle body between described near-end and far-end blocking part, and extend between described near-end and distal tip return tube chamber.Under (1) described blocking-up air bag is contraction state, (2) relative to described retracting device, described actuator wires is distally pushed into the position of far-end actuator wires, and when described actuator sleeve pipe being proximally pulled to the position of near-end actuator sleeve pipe relative to described retracting device, described retracting device can be placed in the first radial collapse configuration.Under (1) described blocking-up air bag is inflated condition, (2) relative to described retracting device, described actuator wires is proximally pulled to the position of near-end actuator wires, and when described actuator sleeve pipe being distally pushed into the position of far-end actuator sleeve pipe relative to described retracting device, described retracting device can be placed in the second expanded radially configuration.When the second expanded radially configuration, (1) described near-end and far-end block air bag and have the radial dimension that is greater than described middle body radial dimension thus limit collecting chamber in central part office, and (2) described near-end and far-end expansion element have open area with what allow fluid to flow through described retracting device and return tube chamber.Side passageway extends via the middle body of described retracting device and the sidewall of described recovery conduit.Except described passage, the part of the near-end and far-end blocking part and middle body that limit described collecting chamber is that liquid is impermeable.Liquid thus from the opening of the fluid handling pipe opened to described collecting chamber can be entered and by described recovery tube chamber by described passage.

Carry out the embodiment fluid being entered body passages by opening being guided to the method for fluid recycling apparatus as follows.Retracting device is positioned at the opening part of body passages by the mode that inflatable and collapsible retracting device is in the first radial collapse configuration with radial direction, and described retracting device has proximal end and distal tip.Described retracting device is placed in the second expanded radially configuration, this placement step is undertaken by least one mechanical actuator element of mechanically actuated at least in part, thus mechanically expand described near-end and far-end blocking part, to make described near-end and far-end blocking part when described retracting device is placed in the second expanded radially configuration have the radial dimension being greater than middle body radial dimension, thus limit collecting chamber at least in part in central part office.Fluid from described collecting chamber is introduced into described retracting device.In certain embodiments, carry out described expanded radially configuration with the first and second mechanical actuator elements of the near-end and distal tip that are operationally coupled to described retracting device and place step.In certain embodiments, carry out described expanded radially configuration by least one actuator element of mechanically actuated completely and place step.In certain embodiments, described expanded radially configuration is placed step and is comprised inflation further and block air bag at the near-end of retracting device and the near-end of distal tip and distal annular rim.

Carry out the embodiment of the method for reclaiming Venous flow effluent from organ as follows, described organ has distal vein and draining vein.Place the vein opening part of funnel device in the tubular body pipe of wanted treating organs reclaiming catheter kit, described funnel device has open end.Place the opening part of open end in the distal vein of described organ of described funnel device.Described funnel device is pressed in make to form sealing between described funnel device and described draining vein on described wall of vein, thus obtains the collecting chamber be limited between described funnel device and described organ.Inject medicament and enter this patient.The fluid from described organ is collected in collecting chamber.Fluid collected by filtration.Return through the fluid of the collection of filter to this patient.

Carry out as follows reclaiming the retracting device of catheter kit for determining and reclaiming the embodiment being sealed with the method for validity of the collecting chamber obtained between the organ of fluid.Injection indicator and therapeutic agent enter patient.The fluid being entered body passages by organ opening is collected in the collecting chamber limited between the fluid recycling apparatus reclaiming catheter kit and described organ.Fluid collected by process.The treating step comprises: remove described indicator and described therapeutic agent from collected fluid.Return treated fluid to described patient.Systemic fluid is collected from described patient.Described indicator whether is there is in systemic fluid collected by test.

Carry out the embodiment of the method removing therapeutic agent from patient as follows.Therapeutic agent is injected patient.Collect the fluid passed through from organ.Interpolation comprises the bond material of affinity agent in collected fluid.Therapeutic agent in collected fluid is combined with described affinity agent.Fluid collected by process and described bond material.The treating step comprises the described bond material removing from collected fluid and there is the therapeutic agent combined with it.Return treated fluid to described patient.

Other features of the present invention, aspect and advantage can be found out by reading accompanying drawing of the present invention, detailed description and claim afterwards.

Accompanying drawing is sketched

Fig. 1 shows the patient with the treatment of prior art spacer assembly.

Fig. 2 display is with the prior art spacer assembly being in contraction state air bag.

Fig. 3 shows the prior-art devices with the Fig. 2 being in inflated condition air bag.

Fig. 4-8 is the illustrative embodiments reclaiming catheter kit, comprises mechanical assistance expansion mechanism constructed in accordance.

Fig. 4 shows the first embodiment of mechanical assistance bloating plant constructed in accordance.

Fig. 4 A shows the structure of the Fig. 4 under collapse state.

Fig. 4 B is the perspective cross-sectional view of Fig. 4 structure.

Fig. 5 A, 5B and 5C are the cross-sectional view along 5A-5A, 5B-5B and 5C-5C line in Fig. 4 respectively.

Fig. 6 shows the substitute of Fig. 4 embodiment, and it comprises the annular air-pocket used in conjunction with mechanical assistance expansion mechanism.

Fig. 7 shows another substitute of similar Fig. 6, and it uses the annular air-pocket of inclination.

Fig. 8 shows the alternate embodiment of similar Fig. 6, wherein described pump and filter is placed on the extension of reclaiming conduit.

Fig. 9-16 shows other embodiments reclaiming catheter kit.

Fig. 9 display comprises the retracting device of funnel conduit.

Figure 10 A and 10B shows the funnel conduit of Fig. 9 in greater detail.

The interim balloon expanding of recoverable type that Figure 11 A, 11B and 11C show under three different conditions supports.

Figure 12 is the cross-sectional view of the line 7-7 along Figure 11 C.

Figure 13 A shows funnel conduit.

Figure 13 B display comprises the recoverable type xegregating unit of inflatable mesh hierarchy.

Figure 13 C shows the structure of Figure 13 B in using.

The extra embodiment of Figure 14, the recoverable type xegregating unit of 15 and 16 display.

Exemplary describes

Below describing usually can with reference to the embodiment of ad hoc structure and method.Be appreciated that and be not intended to limit the invention to specific embodiments disclosed and method, but further feature, element, method and embodiment can be used to put into practice the present invention.Describe preferred embodiment and show the present invention, instead of restriction the scope of the invention defined by the claims.Those of ordinary skill in the art will appreciate that the various equivalent variations in following description.Similar elements is in various embodiments usually by with identical drawing reference numeral labelling.

Fig. 1 is the representative graph of the patient 2 with the treatment of prior art equipment.By syringe 4 or pump (not shown), medicine or material are injected Hepatic artery 5 and pour into liver 3.By double balloon catheter 9 top postcava 7 collect described hepatic venous effluence and guide enter connection tube 17 to pump 21, then by connection tube 41 to filter 43 between pump 21 and filter 43, then by returning blood to the connection tube 44 of interior jugular vein, filtered blood is transported back in the systemic circulation of patient 2.

Fig. 2 is the xegregating unit 139 of prior art, and the air bag 143,144 of non-inflation and the hole 141 in conduit 140 outside are described, described hepatic venous effluence flows into the outside tube chamber placed by this hole.Carry described postcava blood to be in the central lumen (not shown) that must be less than needs to the Returning pipe of right atrium or by tube chamber (not shown) because conduit 142 must contain the recovery tube chamber for described hepatic venous effluence, the inflation pipeline for described air bag and for IVC blood by enter right atrium by returning tube chamber.

Fig. 3 is the prior art equipment 139 having air bag 143 and 144, and the described air bag that expands is to isolate the part of the postcava (not shown) between air bag 143 and 144.Under the hepatic vein (not shown) that afterbody air bag 143 is placed on most afterbody, head airbag 144 is placed the joint portion near postcava (not shown) and right atrium (not shown).As in FIG, flow out inferior caval blood that hepatic vein enters this part isolation and collect by the opening 141 in described catheter wall and enter outside tube chamber, and be delivered to pump 21 and filter 43 by pipe 17,41,44, then get back to human body 2.There is center tube (not shown) as passing back through pipeline from IVC pumping blood to right atrium.Due to the wall of the collected outside pipeline of described xegregating unit, two balloon inflation pipelines and these pipelines, described central authorities pass back through pipeline to be had and is not suitable for transporting the annular space of enough blood to right atrium from IVC.This compression is necessary, because the design of prior-art devices is problematic as mentioned above.And, can find out that taking up room of swelling gasbag 143,144 is that so make greatly may by mistake other important vein inaccessible easily.The present invention can get rid of these problems in one of several configurations described afterwards.

Ideally, equipment of the present invention should be relatively little so that insert, and then expands in described postcava and play function, and then be contracted to small size to remove.In fact, above different embodiments description has discussed inflation, inflatable, self-expanding, balloon inflation, the use of the material of self-constriction etc., the conclusion of the present inventor is after the CT scan that have studied 50 patients, the postcava of all size and shape, cover hepatic vein mouth but not inaccessible adrenal gland and the critical length required for renal veins, to the needs that little afterbody takes up room, with to suitable by return tube chamber need not general demand is proposed to equipment, conduit is reclaimed in other places in vascular system prior art (self-expanding to hepatic venous effluence may be used to by application simply, balloon expanding etc.) described demand can not be reached.Therefore, a preferred embodiment of reference diagram 4 as discussed below and 5A-5C and other embodiments can play best function by the system that mechanical assistance expands, and described system utilization can provide additional tension to strengthen and their expansion auxiliary and a mechanical near-end (such as outer actuator sleeve pipe 73) of contraction and a mechanical far-end (such as actuator rod 154) on near-end and far-end funnel 131,132.Although several embodiment utilizes airbag inflation and an embodiment utilizes self-expanding fabric, preferred configuration is at present the expansion using non-air bag, mechanical assistance, the retracting device 138 of such as Figure 4 and 5 A-5C.

In postcava, the reason that the expansion ratio self-expanding design of mechanical assistance works better comprises following reason.

1. shorten (foreshortening): for self-expanding, described device, once inflation, has the shortening of significant quantity, and the amount shortened can depend on the size and shape of IVC.If described postcava diameter is little, if be large have less shortening compared with it.Need to cover all hepatic veins (being generally from the top to the bottom in the scope of 6.5-7cm), but not inaccessible adrenal gland or renal veins.Therefore, the length of described device is important in use.Usually do not control the length of self-expanding device, and this may cause the obturation of kidney and adrenal veins.Alternatively, length can be controlled, because the tension force that can adjust on described funnel (funnel discussed below 131,132 with reference to figure 4) is to mate the anatomical structure in individual patient with the expansion of mechanical assistance.Therefore, in the patient having little IVC, can be increased in the tension force on described funnel, the length produced when being shorter in length than of generation does not exist this additional mechanical assistance, this just with the addition of the non-existent control element of self-expanding system purely.Single with regard to this reason just strongly impel do not use can only self-expanding design but use mechanical assistance inflated design.

2., in order to effectively basic, self-expanding fabric must be excessive, and elastica must use under excessive state, and less film can cause described fabric to shrink.When attempting to remove described self-expanding device (about 45mm usually by 15Fr (5mm) conduit, abundant inflation is in excessive state), can have to process the extra membrane material that can become irregular folding and condensation when shrinking described fabric.This is real especially when removing distal annular funnel, this is because the middle body of described fabric is connected to described recovery tube, and the near-end tension force of described fabric does not allow it to shrink fully.In other words, perhaps can by removing proximal annular funnel and middle body to the traction of described fabric, but should expect and have a mind to difficulty when adding to excessive distal annular funnel with excessive membrane material in self-expanding configuration removing.The expansion of mechanical assistance and contraction can get rid of this problem.

3. the radial force that self-expanding tubular mesh fabric is usually less than laser cut stent (can be very expensive) applying, therefore may need the expansion of mechanical assistance to obtain to seal closely, namely self-expanding non-existent extra radial tension, particularly consider the many difformities in postcava and angle.In fact, again and again the acute angle existed in the immediately adrenal gland postcava illustrated in above-mentioned CT research can cause specific problem to self-expanding device, because have the improper placement of fabric and the improper sealing of device caused thus due to the acute angle of this position.Can need expansion (i.e. mechanical assistance) initiatively with than pure self-expanding system may (providing) more power drive described fabric.

4. the balance on the size of line and the number of line: can manufacture compacter device with less and less line, if but can have the chance of less radial force and less acquisition tight seal when only utilizing self-expanding.If there is mechanical complementary expansion to provide firmly sealing can build compact device.

5., as described in detail afterwards, the existence being only connected to the recovery conduit of described fabric facies ventralis in Fig. 4 can tend to cause the described recovery conduit when placing in fact prejudicially but to be positioned at the central authorities of described pipe.The use of self-expanding mechanism may cause the pressure do not waited to IVC wall due to funnel, considers the potential more unstable sealing that the shape of described IVC is different and caused thus especially.The use of mechanical assistance mechanism can provide the extra annular tension that can overcome these potential problems.

6. another characteristic of tubular braided structure needs to reach critical braid angle to provide radial strength.When reaching critical angle, described braided tube becomes stronger and the inside power of shrinking needed for described fabric greatly increases.Expand by active expansion or mechanical assistance and more easily can reach the critical angle of described fabric, it can tend to make institute's fabric to have than with the possible larger diameter of pure self-expanding system.In fact, may cannot reach with pure self-expanding device the critical angle that described braiding structure has best braid angle and best radial strength caused thus at all.And even if reach this critical braid angle by pure self-expanding system, in order to regain, fabric described in collapse may be more problematic.

7. self-expanding system needs outer sleeve to limit insertion and the withdrawal of described device.Controlled expansion and the contraction of described device by active system, this outer sleeve may not be needed obtain than by the overall less size of the accessible size of pure self-expanding system.

As subsequently at the mechanical assistance expansion mechanism described in Fig. 4-8 than as shown in some current embodiment in prior-art devices by the reason that the expansion mechanism of air bag can work better being only:

1. the use getting rid of air bag makes described device simpler.

2., when air bag shrinks to allow IVC blood to return heart, only possibly establishment cannot be provided with the secondary expansion of air bag to seal closely or control the power needed for length.

3. can expand in conjunction with mechanical assistance in some cases and use airbag inflation mechanism, and some current embodiments reflect this.

Therefore, for above listed reason, the independently techniques and methods that new mechanical assistance of the present invention is described before expanding and being better than, such as, only use expansion and the self-expanding of air bag.As used in this application, use by mechanical swelling structure in preferred embodiments or carry out the expansion of mechanical assistance without air bag secondary expansion.

Reclaim a preferred embodiment of catheter kit 136 to show in Fig. 4-4B and Fig. 5 A-5C, and comprise use inflatable or expansile and can the retracting device 138 of mesh knitted thing 130 of flexible coating 97 of collapse.Although it can self-expanding, self-constriction, expand it preferably by having described mechanical swelling structure subsequently.

Retracting device 138 in this configuration has " Os Canitis " shape structure having outstanding funnel 131,132 on each end, obtains the blocking element of the hepatic venous effluence collecting chamber 94 (HVECC) limiting the opening 51 covering hepatic vein 52.Knitting skill, the heat treatment of Nitinol (or making other material of fabric 130), fabric 130 is connected to and reclaims conduit 76, limits the shape reclaiming inner liner (lay-in) meeting determining device 138 possible in tube chamber and fabric.Cover or wrap with elastic material 97 by whole except its near-end and distal tip of the mesh knitted thing 130 of device 138, obtain the cylindrical pipe of the modification in tubular mesh fabric 130.Resilient coverings, is generally the biocompatible material of silicon-ketone composition or some other resistance to chemotherapeutics degraded, or other medicaments, can extend proximally into near-end funnel 131 and distally to far-end funnel 132 but can not the end of cladding system 138.This can allow to sufficiently pass through very much Returning pipe 124 and flow into right atrium (not shown) for making blood from the IVC tube chamber 99 comparatively.

Expansion structure 100 can be made up of the expandable frame for movement of radial direction of mesh knitted thing, cut material or any generic tubular, can be expanded to the structure of greater or lesser tubulose, it can allow enough IVC blood return right atrium by pipeline and do not have too many impedance or obturation.The invention still further relates to use the expandable frame for movement of the radial direction of tubulose substantially when collecting hepatic venous effluence by IVC blood from the method being sent to IVC or right atrium barrier film near the region of renal veins, and useful or need not the device that the method is convenient to of extracorporeal filtration system above or described by other places.

In the preferred embodiment of Fig. 4-8, carry out expansion structure 100 by the near-end actuator sleeve pipe 73 of the proximal wire group 146 and distal wire group 147 that are connected respectively to mesh knitted thing 130 and far-end actuator wires 154.By relatively reclaiming the pressure that tube chamber 76 applies forward on outer actuator sleeve pipe 73, near-end funnel 131 can be expanded to postcava wall, produce seal and provide be limited to actuator shaft 73 and elasticity bag quilt mesh knitted thing 130 between the expansion of the proximal part 124 by Returning pipe 124.By the pressure applying to draw in actuator wires 154, far-end funnel 132 can be expanded to postcava wall, produces the sealing of far-end and provides the expansion of the distal portions by Returning pipe 124.Hepatic venous effluence collecting chamber 94 is produced between these two expansion ends of described device.Except producing collecting chamber 94, mechanical swelling structure 100 also produces Returning pipe 124, discusses in more detail following.

Blood and chemotherapeutics is collected and the recovery conduit 76 transferring them to external pump (not shown) is bonded to the ventral surface of the inflatable mesh fabric 130 of bag quilt from HVECC94.Place at least one hole 95, and preferably multiple hole 95, entered by fabric 130 and bag the tube chamber 68 reclaiming conduit 76 by the material 97 of described fabric.See Fig. 5 A-5C.This allows exchanging of inner chamber 68 and the HVECC94 reclaiming conduit 76 and described hepatic venous effluence can flow into from HVECC94 passing hole 95 and reclaims conduit 76, is then transported to external to return described human body after filtration.

The combination of described conduit and described braiding structure is special concern, because this may be potential failed point.Simple circumference around hole 95 in the hole of the wall by scheduling apparatus 130 and recovery conduit 76 may be enough in conjunction with (not shown), but prediction may need the surface of described conduit to combine to the region widely of described braiding structure in conjunction with (not shown) and concentrated circumference, and it can provide extra degree of safety.Except combination described above, miscellaneous part (not shown) can be utilized, such as line, wraps the mesh knitted structure 130 of quilt with fixing described recovery conduit extremely described mesh knitted structure around reclaiming conduit 76 and connecting (engage).Preventing toxicity hepatic venous effluence from leaking and entering systemic circulation is high relative importance value.

Because the braiding structure 130 of bag quilt is combined at the roughly mid portion of braiding structure 130 in recovery conduit 76, if the collapse of described fabric can than it not in conjunction with time more difficult, this is because described proximal mechanism can not the far-end of braiding structure described in collapse.So, in this specific embodiment, in the wall reclaiming conduit 76, supply the second contracting mechanism (see Fig. 5 A-5C) with the form of occupy pipeline 69 rigid push/pull bar or actuator wires 154.By crimping, soldering or the distal wire group 147 of braiding structure 130 is connected to this bar or line 154 by other suitable mode.Recall line 154 braiding structure 130 can be caused to abut against blood vessel wall 155 expand and form the sealing 156 around the HVECC94 that can produce.Before push away line/bar 154 can cause braiding structure 130 collapse for insertion and remove.Can be expanded and the proximal part 131 of collapse braiding structure 130 relative to reclaiming the activity of conduit 76 by actuator sleeve pipe 73.

It should be noted that the character of the bias of the recovery conduit 76 in Fig. 4 and 4A especially.The fabric 130 being connected to actuator sleeve pipe 73 near-end by proximal wire group 146 can tend to reclaim conduit 76 and be placed in tube chamber 99 central authorities of described blood vessel IVC.Ideally, reclaim conduit 76 to need to keep being placed on prejudicially to keep backward channel 124 large as much as possible in the tube chamber 99 of described blood vessel, so that blood unhinderedly flows.Because fabric described in the degree of eccentricity may not provide the equal pressure of blood vessel wall 155 at funnel end 131,132, this may cause the unequal sealing of HVECC94.The feature of these passivenesses partly can be overcome by different knitting skills, thermal finalization technology and extra inner liner etc. the technology for braiding 130.Extraly, fabric 130 member (i.e. proximal wire group 146) being connected to actuator sleeve pipe 73 in the veutro of described device on can be shorter, it may contribute to solving this difficulty to a certain degree, and the distal wire group 147 of fabric 130 is connected to the far-end tensioned thread 154 being really positioned at vessel lumen 99 central authorities.In other words, near-end fabric 146 can provide the radial force to near-end funnel 131 annular with actuator sleeve pipe 73 connection by this way so that the Forward pressure on actuator sleeve pipe, and described connection is necessary to providing for the tight seal of IVC wall.Do not have the pressure that this adds, the eccentric character of funnel 131 may prevent the equal or suitable pressure for IVC wall 155, particularly because the size and shape of described IVC is from patient to patient, is even difference like this in same patient.

Another alternate embodiment as shown in Figure 6 utilizes mechanical assistance expansion gear as shown in Figure 4, but mechanical assistance is only used for expansion backward channel 124.On the near-end passing through backward channel 124 and distal tip, limit HVECC94 by air bag 180,181 (it can be annular air-pocket).The existence of described mechanical assistance bloating plant can overcome the intrinsic problem of many self-expanding devices listed herein and allow easier placement and reorientation, easier use, and more importantly, the easier recovery of tubulose retracting device 138.Mechanical assistance expands and also can allow larger pressure that radial direction can apply and prevent the collapse of Returning pipe 124 airbag deployment 180,181 time.Described air bag, more flexible than the braiding funnel 131,132 in other embodiments, the acute angle in described postcava can be met better than described litzendraht wire structure and provide more consistent with foreseeable sealing.Never problem in the leakage of the prior-art devices in the current use utilizing air bag.Described air bag function is well to comprise hepatic venous effluence.The problem of prior-art devices is described air bag too large and inaccessible kidney and adrenal veins in some cases, and described too little so that do not transmit the blood of enough volumes to heart by described postcava from kidney and lower limb by Returning pipe.This problem below causes patient to suffer a shock, and various before cited other problems.Therefore, described air bag is not the problem of the prior-art devices used at present, but the size of described air bag and have problem by the size returning tube chamber.Solve these defects by various embodiment, comprise Fig. 6 and 7 those.

As existing embodiment, wrap by the tubular structure woven with the impermeable of resistance to chemotherapy compound and resilient material 97.It is tubulose substantially, instead of the end having funnel 131,132 as shown in Figure 4 or expand.The tubular structure that representative returns tube chamber 124 is connected to the internal recovering conduit 76 be connected with hepatic venous effluence collecting chamber (HVECC) 94 by one or more hole 95.Outer actuator sleeve pipe 73 is slidably with the expansion of auxiliary tubular Returning pipe 124 and collapse relative to internal recovering conduit 76.Fabric 130 is connected to this recovery conduit 76 to make by tension force being provided to expand described fabric relative to pushing away outer actuator sleeve pipe 73 before internal recovering conduit 76, or assist the described fabric that expands, and regaining outer sleeve 73 by relative interior conduit 76 can provide tension force to carry out fabric described in collapse, or assist to shrink described fabric more completely.

Rigid line or the actuator wires 154 of pushing away can be connected to distal wire group 147 to expand or to shrink, or secondary expansion or the tubular braided structure that shrinks as previously shown in Figure 4.Expansion or secondary expansion is completed by recalling line 154 relative to internal recovering conduit 76.By completing pipe-type woven by the contraction of Returning pipe 124 or auxiliary contraction relative to pushing away line 154 before inner conduit 76.Line 154 is preferably placed according to Fig. 5 A, 5B and 5C in the tube chamber 69 of inner conduit 76 wall.

As in Fig. 5 A, 5B and 5C describe, described proximal balloon and distal balloon are connected to described pipe-type woven by returning the outer surface of tube chamber and by inflation tube chamber 66,67 inflation, but described inflation tube chamber may be placed in and is different from these positions shown in the drawings in inner conduit 76 wall.These two air bags 180,181 are orientated be approximately perpendicular to inflatable by Returning pipe 124 and by annular shape around inflatable by returning tube chamber 124.Air bag 181 by head location may be larger than the air bag 180 more by afterbody, because it may be favourable that the head end of described device and described head airbag are placed in right atrium.Inferior caval part between described right atrium and hepatic vein 52 than the postcava large (CT carried out from above-mentioned the present inventor determines) of suprarenal, therefore needs the larger air bag or other sealing devices that are provided in head usually.Because described near-end and distal balloon be all orientated be approximately perpendicular to described by returning the axis of tube chamber, describedly to take up room much smaller than the spherical envelope of current prior-art devices, and therefore the obturation of adrenal gland and renal veins is debatable hardly as prior-art devices.

Alternatively, elastic coating 97 can the described mesh knitted thing of a cover part, as discussed in fig. 14.If this is the case, airbag structure (not shown) can substantially around or surround described HVECC94 to limit it, instead of two of Fig. 6 annular air-pockets 180,181.

And, described CT research illustrate left side renal veins 182 (in Fig. 7, its be described device in IVC from front portion or the see-through view of head) always locate more something or somebody to fall back on portion than right side renal veins 183.This also illustrates that Accessory hepatic vein 184 enters described IVC from veutro or from right side.Therefore, may be favourable, place afterbody annular air-pocket 180 with the angle shown in Fig. 7 more rearwardly to extend to avoid inaccessible Accessory hepatic vein 184 and the Accessory hepatic vein effluent of catching from HVECC94 on right side to make described HVECC94, but more extend to provide safety range to avoid by mistake inaccessible left side renal veins 182 to head in left side, described left side renal veins is with the axle horizontal location almost identical with the Accessory hepatic vein 184 of most afterbody.Extraly, joint portion, caval vein atrium is often also asymmetric and can utilize inclination air bag at two ends to adapt to the anatomical structure of the uniqueness existed in IVC on near-end and kidney better.The annular air-pocket 810 of the inclination in use Fig. 7 overcomes the needs when there is asymmetrical anatomical structure in reality for near-end and far-end occlusion structure (expandable braid or spherical envelope) symmetry.

The existence in vitro of described pump and filter is inconvenient and creates extra step.Described pump and filter can be completed to be placed in by pump described in miniaturization and filter assemblies and to reclaim in conduit and the blood returning through filter need not be transported to external position to systemic circulation.The reduced graph of the recovery conduit 76 that Fig. 8 display is similar with Fig. 6, described conduit has filter 43 and pump 21 in the extension of conduit 76.Described extension is traversed right atrium 200 and is entered superior vena cava 201.The existence that pump 21 abuts against the near-end of hepatic venous effluence collecting zone 94 has extra benefit, obtain the negative pressure region in hepatic venous effluence collecting zone 94, also prevent any leakage entering systemic circulation, because if collect in 94 regions at hepatic venous effluence and have pressure low in than IVC99, then do not have the chance of leaking and entering the IVC of more high pressure.Pump 21 can be the one in the pump of three kinds of general types that can promote blood, i.e. roller, centrifugal and axial type pump.In these types, centrifugal pump is the most applicable this application probably, because they usually cause less haemolysis than other types and can more easily miniaturization.Centrifugal pump is made up of the impeller blade of the pump head of non-blocking and the usual electromagnetic propulsion be positioned in valveless pump case of various number.The rotation of pump produces and causes the eddy current without pulsation unidirectional blood flow and can realize high flow rate, but the pressure differential that described centrifugal pump can stride across (bridge) is limited.In the purposes of the present invention's expection, there is the vein not needing remarkable pressure differential to the blood flow of vein.At present, a few company produces centrifugal pump, comprises Medtronic, Sarns and St.JudeMedical etc.The pump of exploitation for neonate use can be revised for the use in the application.Axial pump is made up of the rotor-type impeller be contained in little housing and carrys out driving device activity by the rotor-support-foundation system of Electromagnetic Drive.Embodiment is the Impella pump from ImpellaCardiotechnikAG, or even MicroMedDeBakeyVAD.In another embodiment, only pump 21 can be placed in conduit (not shown), and filter 43 remains on external.

Filter 43 for the embodiment of Fig. 8 can be one of several types, include but not limited to the filter assemblies of electronics, filter cylinder, film, microtubule, microfluid, magnetic, chemistry, active carbon, band plus or minus electric charge and other.This filter cell can be produced from any suitable medium, such as can by absorption or bound drug molecule to loose structure, anion exchange, particle filtering, gathering filtration etc. extract from blood medicine based on carbon or synthesis medium.Filtration device structure can be hollow-fibre membrane, semipermeable membrane, granular media, weave or weaving filter fabric or other suitable form.Described filter can be expandable (not shown) after being inserted into, if particularly the efficiency of described filter depends on the surf zone of described filter, preferably in superior vena cava 201 or right atrium 200 to allow filtered blood be back to superior vena cava 201 or right atrium 200 and be not transported to external.When charcoal filter, adsorption effectiveness may pin several to dissimilar, i.e. ROX, UKR, CLA etc., active carbon and shape and configuration of surface be different.Can with polymethyl methacrylate copolymer or some other material with different-thickness with differently wrap by described granule, to reduce the effect on erythrocyte and other blood constitutents.The balance between coating layer thickness and adsorption efficiency may be had frequently.The filter of operable another type is containing can with the filter of the porous hollow fiber of affinity substance bag quilt, or described affinity substance can in the inside of described doughnut or outside.Can blood described in pumping by described porous hollow fiber, and optionally transport the material that will the remove space to described doughnut outside, or on the contrary, can optionally be transported the material that will the remove inside to described doughnut by the space of described fibrous external by blood described in pumping.

The blood filter of another type is microfluid blood filter.Use current equipment use, as before in fig. 8 described by as described in chemotherapeutics inject and collect, but the oxidation iron shot of the blood containing described chemotherapeutics with the bag quilt being coated with affinity substance to be mixed when entering recovery tube chamber 76.Described chemotherapeutics can depend on described bag by pearl and be pumped through filter 43 with blood, and wherein electric magnet (not shown) can be separated described pearl and chemotherapeutics from blood.Consider the space constraint of conduit internal filter, this system has advantage because it can get rid of the volume required by traditional design.Also the mixer filter adopting one or more different filter type in same device can be used in.

Can by the pressure of pump 21 or expanded filter 43 by other means.As in other embodiments several, blood from hepatic venous effluence room 94 passing hole 95 can enter recovery conduit 76 and advances to head in the extension of reclaiming tube chamber 76, leaves enter superior vena cava 201 or right atrium 200 by pump 21 and filter 43 and by the distal tip of described device.The side opening 203 being provided for rigid actuator rod 154 and leaving can reclaimed in conduit 76.Alternatively, actuator rod 154 can be connected to the actuator sleeve pipe (not shown) of separating being positioned at recovery conduit 76 outside can be also slidably relative to recovery conduit 76, reclaim conduit 76 and be connected to tubular braid in this position, the actuator sleeve pipe (not shown) that the withdrawal of actuator rod 154 can be moved apart is to the described fabric that expands, and the actuator sleeve pipe (not shown) that the advance of actuator rod 154 can be moved apart is to shrink described fabric.

Another embodiment (not shown) utilizes as the self-expanding Returning pipe 124 in Fig. 6 and annular air-pocket 180,181, but does not have as the active expansion system in Fig. 6 and 7.When described active mechanical expand auxiliary be provided in the control do not had in pure self-expanding system time, the expansion provided by airbag deployment assists the radial strength that can provide enough in the present embodiment that to combine with the described self-expanding structure by returning tube chamber to keep described by returning the unobstructed of tube chamber.Can provide sealing function by described air bag, if therefore picture self-expanding assembly described in this specific embodiment is the situation by returning tube chamber, some the bad quality as self-expanding system listed are before incoherent.In other side, the function in the present embodiment and assembly be identical substantially in Fig. 6 and 7.

Other reclaim catheter kit

Fig. 9 shows another embodiment reclaiming catheter kit 136, comprises retracting device 138.Retracting device 138 comprises the funnel conduit 50 of the opening 51 covering hepatic vein 52, isolates described hepatic venous effluence and regain described hepatic vein blood entering conduit 53 or enter filter 43 with tube pump and be back to described human body (as in Fig. 1).Support by the interim recoverable type balloon expanding that the venous duct 55 that separates provides the position that 54 keep funnel conduits 50, be anchored on hepatic vein mouth 51.Balloon expanding supports 54 and comprises the mesh support 77 limiting open architecture 79.Make the length of interim recoverable type support 54 longer than funnel conduit 50, because the end of described funnel conduit can be fixed to the postcava 56 of veutro by further by design.Support 54 and also press the periphery of funnel 50 to guarantee the sealing closely of the veutro aspect of postcava 56.The surface of pressing the support 54 of funnel 50 may be indentation or have concave surface 58 so that not inaccessible funnel 50.The open architecture 79 supporting 54 can not flow into, even if it covers them by the inaccessible vein from kidney or adrenal veins.This design solves the two problems of above-mentioned prior-art devices, the obturation of kidney/adrenal veins and lack and pass through Returning pipe for the suitable of IVC blood.Funnel conduit 50 (tilted shape) is depressed into the veutro aspect of near-end IVC56 to fix its not inaccessible kidney/adrenal veins on hepatic vein mouth 51 by temporary support 54.Funnel conduit 50 takies very little annular space in IVC56, and to allow when the air bag 60 in temporary support 54 is deflations, blood freely flows into right atrium from middle and distal end I VC56 by the space temporary support 54 or space 59.

Figure 10 A and Figure 10 B illustrates in greater detail funnel conduit 50.It comprises (or other suitable biocompatible material) mesh knitted thing 63 of two axles 61,62 and Nitinol, and described mesh knitted thing 63 is by silicone elastomer (not shown) or other inflatable and the resistance to chemotherapeutics material bag quilt of degrading.But the unique distinction of the application is, two axles 61,62 of funnel conduit 50 are the angle of inclination in their distal tip 64, to make funnel 50 outstanding to the side of described conduit, instead of stretch to the far-end of funnel conduit as in the state of the art.In Figure 10 A, regain interior axle 61 relative to outer shaft 62.This keeps the mesh knitted thing 63 of funnel 50 in the tube chamber of outer shaft 62.Mesh knitted thing 63 is bonded to interior axle 61 and outer shaft 62.When regain in axle 61 time, mesh knitted thing 63 forms columniform pipeline and is parallel to and is positioned at the pipeline formed by outer shaft 62.As shown in Figure 10 B, when distally before pushing away interior axle 61 to two thes tip of the axis, mesh knitted thing 63 is pushed out the distal tip of outer shaft 62 and forms funnel 50.And, shape and the intensity of funnel conduit 50 can be affected by what add longitudinal, level with the inner liner tilted.The shape memory characteristic of NiTi and the ability these being had the inner liner of particular characteristics to be placed on the described ad-hoc location than fabric allow the device of adjustment braiding structure to be used for specific application.The combination of the NiTi be combined with knitting skill guarantees that almost any shape is possible substantially.In fact, different from method before with the description covering hepatic vein hole to formation shape in this paragraph, it is entirely the funnel distally extending described catheter tip.Also this structure can be used in other discussed in this article embodiments.

Figure 11 A, 11B and 11C represent the interim balloon expanding of recoverable type and support (RTBES) 54.In Figure 11 A, expanding support 54 on airbag deployment 71.Described conduit contains two axles, outside one 73 and inner one 76.Described air bag is connected to interior axle 76 and by connection 77, RTBES54 is connected to outer shaft 73.As directed, at the far-end of air bag 71, support 72 fabric 77 in conjunction with 69 to interior axle 76.

The air bag 71 that Figure 11 B will tighten when being presented at expanding support 54.Relative to interior axle 76, the power (arrow) forward on outer shaft 73 can be assisted and be kept support 54 to expand to described IVC wall (not shown) and described funnel conduit (not shown).The space 79 supporting 54 provides enough spaces for blood flows into right atrium from IVC.Funnel conduit 50 is pressed in described veutro vein and the position secured it on hepatic vein mouth 51 by the pressure carrying out self-supporting 54.RTBES54 can be inserted by internal jugular vein or femoral vein, also so can insert described funnel conduit, but they two usually can be inserted by different veins.And, the axle 76 of RTBES54 can be utilized after described hepatic vein blood is by described filter as Returning pipe, because it can not have other objects when carrying out liver perfusion.If utilized by this way, insert it preferably by internal jugular vein.Extraly, the axle 73,76 of RTBES54 can have along axle 73,76 the opening (not shown) entering tube chamber, and the blood returned to make some can guide and enter described superior vena cava.

In Figure 11 C, regain outer shaft 73 (arrow) relative to interior axle 76, to shrink the support 54 on air bag 71 because outer shaft 73 proximally in conjunction with 77 to support 54 interior axle 76 distally in conjunction with 69 to support 54.This can allow to insert and apparatus for removing 55 in lower configuration (lowprofile).

Figure 12 is near the cross section of air bag 71 with two axles 73,76 of the device 55 of support 54.Which show interior axle 76 and outer shaft 73.Interior axle 76 comprises large tube chamber 68 and the inflation of at least one less tube chamber 67 for air bag.Can exist another tube chamber 66 for insert seal wire (not shown) or for injecting contrast this.Also contrast agent can be injected by the space 65 between interior axle 76 and outer shaft 73.

Figure 13 B and 13C discloses the mesh knitted structure 80 of recoverable type self-expanding or balloon expanding.It can be carried by funnel conduit 81 and regain, and sees Figure 13 A, is probably not similar with the funnel conduit 50 in Figure 10.This funnel conduit 81 can be simpler, is that funnel conduit does not require obturation or isolation in such an embodiment, and at the axis guiding funnel 82 of described distal end of catheter end along described conduit axle.In fact described funnel conduit may even do not needed.

In Figure 13 B, described xegregating unit is recoverable type self-expanding with elastomeric material (not shown) (such as but not limited to silicone) the institute bag quilt of the chemical property of resistance to concentrated chemotherapeutics or balloon expanding mesh knitted structure 80.Elastic coating (not shown) can cover this tubular structures 80 all, or only covers the half of veutro in preferred embodiments.The structure of the latter can stop inaccessible kidney or adrenal veins.In this specific configuration, described isolation room equipment is tubular mesh basketwork structure 80, and it has the side arm 83 of the main tube cavity 84 being inverted into structure 80.By this inverted side arm 83 in conjunction with 85 to transporting hepatic venous effluence to the recovery tube 86 of external (described filter crossed by its pump in vitro).Alternatively, the recovery tube chamber 76 that recovery tube 86 can be similar to Fig. 4 connects like that.Also show the tether silk 88 being connected to structure 80 to be used for removing to make being taken in funnel conduit 81.Described mesh knitted structure 80 can be connected to alternatively and reclaim tube chamber 83 and non-inverted side arm, as shown in above Fig. 4.

As shown in figure 13 c, veutro aspect containing the recoverable type tubular structure 80 being inverted side arm 83 contains concave surface 87, and concave surface 87 is even as big as covering the opening 51 of hepatic vein 52 and being inverted side arm 83 and recovery tube 86 to outside as little reservoir to guide hepatic venous effluence passing hole 88 to enter.Such an arrangement provides the isolation of effective hepatic vein and very sufficient being passed through to right atrium for IVC blood by Returning pipe, solve the subject matter of prior-art devices.

Figure 14 shows callable xegregating unit 90, wherein by the pipe 91 to outside directly in conjunction with (not shown) to equipment 90 to be more flexibly inverted side arm 83 wall on, as in Figure 12.The wall of callable xegregating unit 90 has concave surface 93, and it covers hepatic vein mouth 51 and enters pipe 91 as little reservoir 94 with guide blood passing hole 95.Those in other characteristics and Fig. 8 B and 8C are similar.In Fig. 8 B, 8C and 9 two inventions, can provide around described collecting chamber the elastomeric material 96 of extra layer or multilamellar or even airbag structure (not shown) to strengthen sealing.The special knitting skill (not shown) of described fabric also can strengthen sealing over these locations.Because hepatic vein enters IVC from veutro or from right side, elastic coating can be limited to these positions instead of around.Extraly, in the embodiment of the equipment in Fig. 8 and 9 that elastomeric material 97 covers in the veutro of described equipment and right side, extra encapsulating method 96 described above can substantially around concave surface described above to provide more effective sealing.Also tether silk 99 is demonstrated.

The expandable mesh knitted thing of flexible coating 97 can extraly containing the funnel-shaped structure (not shown) on two ends to provide the isolation of described hepatic vein blood.Described end can comprise self-expanding material (not shown), such as, described end can be caused to open and contact described IVC wall to provide the NiTi of extra sealing characteristics with the power of dosage.

Figure 15 is presented at and builds another structure upper and that Figure 11 A, 11B and 11C are similar, and wherein utilizing is that the interim balloon expanding of recoverable type supports (RTBES) 98.But RTBES98 is not used to funnel conduit 50 to compress in the veutro of described IVC in this specific configuration.RTBES98 contains the collecting chamber 101 playing function as funnel conduit 50 in embodiment before.To be expanded this RTBES98 being shunk, as shown in Fig. 6 A, 6B and 6C by axle 76 and outer shaft 73 in operation by airbag deployment 71.Cover the veutro aspect at least supporting 98 with elastomeric material 97, but described elastomeric material can cover all structures except far-end and proximal end, and can have at least in part around the extra elastomeric layer 96 of collecting chamber 94, as in Figure 14.By establishment technique, use inner liner etc. can control the shape of this and other structure.As in embodiment before, can hepatic vein collecting pipe 91 be guided to external, but can guide to alternatively and be bonded to the far-end aspect of as directed inner chamber 76.The cross-sectional view of Figure 12 can be applied in this case and described hepatic vein blood can be guided through large central lumen 68.

Figure 16 shows another structure, wherein utilizes the recoverable type self-expanding mesh knitted thing device 110 of flexible coating 113.This pair of funnel 114 structure, wherein the end 114 of device 110 expands and is greater than described middle body.The central part branch of equipment 110 is by reclaiming at least one in conduit 112, but preferably multiple hole 111 is bonded to recovery conduit 112.The pressure that described end adds can obtain effective sealing, isolates described hepatic venous effluence and guides the hole 111 entering and be connected to and reclaim conduit 112.The tether silk 110 of the proximal end at device 110 can be connected to the axle reclaiming conduit 112, or be combined together to form single tether silk (not shown) for apparatus for removing 110.In this embodiment, reclaim conduit 112 and extend through the whole length of equipment 110 to provide certain rigidity and the object of pushing away property for placing, operating and remove to described device.But it may not the whole length of extension apparatus 110.

Described knitting skill can produce the dilatancy having more the fabric of inflation and less in middle body on the end of described structure usually.The welding of the silk in described fabric central authorities can be utilized to obtain and to be less than described distal tip and the middle body that can insert horizontal inner liner.Combination in hole 114 in device 110 veutro can help to obtain the little reservoir at core for hepatic venous effluence.Described funnel shaped end can have than less the taking up room of swelling gasbag in Fig. 1,2 and 3 prior-art devices, and should be unable to inaccessible renal veins.But, around in the dorsal part of the distal tip of device 110, the part of fabric 123 can be covered without elastic coating 113.This can allow blood to be flowed into by Returning pipe 124 from kidney or adrenal veins by open mesh.

Reclaim conduit 112 end 117, the distal tip of device 118 and the proximal end 119 of device 110 can have maybe can not have ray not through mark.Alternatively, mark (not shown) can on equipment 110.

Usually can be carried and apparatus for removing 110 by funnel conduit 120, described funnel conduit is the mesh knitted thing 122 with elastic coating 113 be contained in outer sleeve 121.In use, the outer sleeve 121 containing all above assemblies can insert in described femoral artery or internal jugular vein, and when internal jugular vein inserts, tip is positioned most afterbody hepatic venous immediately below.When remaining on the pressure reclaimed on conduit 112 forward, described outer sleeve and funnel conduit 120 can be regained with operative installations 110, as shown in Figure 16.Described proximal end can in the hepatic venous head side of most head.Can pour into described Hepatic artery with the medicament selected, passing hole 114 is collected hepatic vein blood and is pumped across external filter and returns described human body, as in Fig. 1 in recovery conduit 112.Alternatively, by funnel conduit 120, filtered blood can be back to described human body.When stopping described process, outer sleeve 121 can be regained to expose funnel 120 above funnel conduit 120.Then conduit 112 meeting is reclaimed by funnel conduit 120 retraction mechanism 110 by regaining.When device 110 is in funnel 120, the funnel 120 can regained containing device 110 enters outer sleeve 121, and removes whole equipment.Reoffered fully by returning tube chamber, effective collecting chamber exists, and provide the mode preventing kidney and adrenal veins obturation.

Another structure (not shown) of this equipment utilizes expandable funnel to carry out inaccessible described IVC afterbody to most afterbody hepatic vein (being similar to Figure 16) and air bag with the top IVC immediately below inaccessible right atrium.In other words, the enlarging 114 of Figure 16 can tail end (in left side) in figure 16 exist, and airbag structure (not shown) can exist in described head end.Can be the section having the self-expanding of the elastic coating being similar to Figure 16 to weave as returning the central lumen passing back through pipeline of IVC blood to right atrium.The hepatic vein blood flowing into described hepatic vein collecting pipe do not have pipeline separately in described isolation section, as in the prior-art devices in Fig. 1,2 and 3.Described hepatic venous effluence be collected in inflatable by the space of backward channel outside and guide enter described recovery conduit, its be conducted through one repeatedly in the air bag in head end.Balloon inflation chamber can be contained in the wall of the axle of hepatic vein collecting pipe discussed before.The head end returning tube chamber in the described central authorities of right atrium can have the mesh knitted thing that opening maybe can comprise nonelastic coating to allow described IVC blood to leave this central lumen, and described IVC blood flows through the space of described fabric.In the structure shown here, funnel distally can provide the isolation of the obturation of described IVC and described IVC hepatic vein section with very little taking up room, get rid of the obturation of kidney and adrenal veins, and the combination by Returning pipe of the funnel shaped combination of the described tail hole by the inflatable section of Returning pipe and described expansion can provide pipeline very fully freely to flow to right atrium from IVC for blood.This configuration is the feasible substitute of prior-art devices.The use of air bag admits that funnel-form occluder in most of the cases can show better true than air bag occluder, because several reason, comprising the ability namely opened/namely close, more much smaller to take up room, larger by tube chamber etc., may be need at IVC and right atrium intersection with the obturation that takes up room greatly really.

Above method is also conducive to the moderate obturation obtaining top IVC, and it may obtain the pressure of described IVC to the increase of hepatic venous effluence collecting region.The obturation of the blood returned described in eliminating is one of main target of the present invention, because as described above, too many obturation can cause the lower degradation of blood pressure.But the obturation obtaining the moderate controlled may be desirable, and its pressure increasing described IVC enters IVC higher than the pressure in hepatic venous effluence collecting region to prevent the leakage of hepatic venous effluence.Complete by air bag or by other modes being incorporated to the design of described device, such as, diaphragm type device by being controlled by operator.Can in the IVC of top and in hepatic venous effluence collecting chamber, pressure transducer be provided to be with or without the pressure in these two regions of baffle plate device with monitoring.Can by providing along the silk of conduit axle or by utilizing wireless pressure sensor.In this specific structure, the sealing around hepatic venous effluence collecting chamber not only prevents the leakage entering IVC or systemic blood from described room, and prevents the leakage entering this room from IVC from being necessary.

Should be understood that pressure transducer to detect in the pressure of described hepatic venous effluence and described IVC or right atrium the pressure reading of at least one.By connecting described pressure transducer to controller and described controller extremely described external pump, described pump can be regulated to have in hepatic venous effluence than pressure lower in IVC always.If the pressure of the pressure in described hepatic venous effluence and described IVC becomes close, or the pressure even exceeded in described IVC, then described controller can accelerate described pump to make to extract more blood from hepatic venous effluence collecting chamber, thus the pressure reduced in this collecting chamber is extremely safely lower than the level of pressure in IVC.This can guarantee not have the leakage of hepatic venous effluence (lower pressure) to enter whole body IVC (higher pressure), if there is any leakage, it can be enter hepatic venous effluence collecting chamber and this can not be harmful from IVC.Can automatically complete speed by controlling described pump and output and the adjustment of the pressure carried out with described controller, or come by the operator of pressure or the manual adjustment of assistant to the speed of described pump that manually monitor hepatic venous effluence collecting chamber and IVC and/or right atrium alternatively.Alternatively, can run with a kind of speed described pump programming, or effectively can be kept the controller of the single pressure sensor of the pressure in HVECC by utilization, or by directly measurement or the measurement by extrapolation, be less than 1-2mmHg (normal pressure in right atrium) or left and right.This pressure that can ensure in HVECC is less than the pressure in IVC/RA, and therefore can not enter the leakage of the system of more high pressure from the system of power at low pressure.In certain embodiments, before described process, manually obtain pressure in described IVC so that can need to only have a pressure transducer near described pump carry out the speed of control pump and remained on by the pressure of this sensor and be less than the determined IVC pressure when described process starts.

Another optional method (not shown) utilizes two air bags as the blocking element at head and afterbody, but described be inflatable by means of the conduit in such as Figure 11 A, B and C by Returning pipe.This can utilize the certified inaccessible feature of described air bag, but inflatablely enough large pipeline can be provided to return IVC blood not to have current device quite not enough tube chamber to right atrium by Returning pipe.The supravasal support of Figure 11 A, B and C the internal circumference of outside compressing gasbag and inwall can obtain more annular space in the central open region of described air bag and tube chamber.In the space isolated by two air bag blocking elements, collect described hepatic venous effluence, be then transported to human body outside.This can realize by conduit cavity separately or by the main tube cavity of the conduit of Figure 11 A, B and C.

In the revision (not shown) of the embodiment described in above paragraph, to utilize self-expanding equipment to obtain in the central authorities or " bagel " of described air bag inflatable passes through Returning pipe.This can be similar to the embodiment of above paragraph, but described support can not use the 3rd air bag and expand.Described inaccessible air bag can from periderm compression in them, and expanding it consequently provides suitable pipeline.The airbag structure of the center tube of expansion is had to be called as annular air-pocket.For limiting being positioned at annular air-pocket structure on each end of described device and can combining with from expandable structure (such as mesh knitted thing or other from expandable structure) and be arranged on conduit 73 of the border of hepatic venous effluence collecting chamber (HVECC), as shown in fig. 4 and fig. 6.Described air bag (not shown) can increase or funnel 131,132 in alternate figures 4 or place as shown in Fig. 6 or Fig. 7.In other respects, the version of this amendment can be similar to Fig. 6 substantially.

Another carries out organ perfusion when providing blood flow with toxicant and the diverse method of collecting Venous flow effluent can be utilize prior-art devices or similar device, it does not have suitable to returning tube chamber, but add the second extra conduit system and, if necessary, add pump, then return it to the systemic circulation except collecting the point (being generally superior vena cava) of Venous flow effluent for transporting blood from bottom IVC or some other regions to external.This substantially can obtain external bypass loop and may be functional, although because the conduit, puncture, pump, equipment etc. that add may have problem.Special return conduit (not shown) can have two and return tube chamber: a hepatic venous effluence for being filtered, and another branches to external whole body IVC blood for the obturator walking around the device generation using prior art type.This can get rid of the needs to two return conduits.The invention solves and lack the suitable problem by Returning pipe, and without recourse to this relatively loaded down with trivial details method.

For preventing movement or the migration of the described device in filling process, to can be provided in or near bindiny mechanism's (not shown) of described skin insertion point.From the stitching thread being connected to tissue, the clip to skin level, prevents the component of described conduit movement to anchoring device or any other, and it may be constructively different.

The method of all above embodiments is utilized to be very similar.Imaging research is as the distance between the point directly over CT scan, MRI or other placement locations for the most something or somebody to fall back on side (cepahalad) of blocking element of expanding as described in weighing (no matter it is IVC on joint portion, caval vein atrium or diaphragm) and renal veins.Also the measurement of the size of described IVC is obtained.Select the retracting device of appropriate size, the device 138 of such as Fig. 4-8 of the present invention.Normally, from femur puncture, conduit is placed in the suitable tremulous pulse of liver, for subsequently by the liver perfusion of the high dose material concentrated.In a structure or other structures, place in described IVC and use device of the present invention to cover hepatic vein mouth to make xegregating unit.The end in the more something or somebody to fall back on portion of described device can be placed in IVC (normal length is 1-3cm) in right atrium or on diaphragm.When the structure of the enlarging of some embodiment, if with in right atrium, place this device and draw described device in joint portion, caval vein atrium for generation of compared with sealing, the enlarging of far-end may adjoin larger radially to the power of the power of IVC wall on described diaphragm and the sealing annular of the described IVC wall of guiding.By with retrograde manner injecting contrast thing by reclaiming conduit and entering HVECC and determine not carry out testing to determine that whether described placement suitable from the leakage of this isolation section.Inject radiography thing to enter distal end I VC and flow to right atrium with passing back through of defining.Test can assess renal veins and adrenal veins and adjustment to provide the state of the equipment of the flowing from these veins.Hepatic venous effluence can be collected and hepatic arterial infusion can start.Within a period of time as in prior-art devices, can by described Venous flow effluent pump to external and filter and be back to human body.After described arterial perfusion completes, described Venous flow effluent is collected and process can continue time of specifying and to enter washing out of any delay of systemic circulation from liver to prevent the high dose material that concentrates.Through after a while, then can shrink, recall and remove selected equipment from human body.

When preferably carrying out described method from internal jugular vein, predict the route map that can be completed anatomical structure by the radiography thing of the filtering blood return conduit punching note in femoral vein, and can carry out because blood can flow to heart to central authorities with the placement of described equipment simultaneously.This supravasal side arm can provide when keep filtering blood return flowing time injecting contrast thing mode.This can to monitoring that during described process the placement of described equipment be valuable and current prior-art devices is infeasible.

What it should be noted that the feature of above listed ad hoc structure can use to be provided in the isolation room in IVC interchangeably with other structures less take up room and passes back through tube chamber to be back to right atrium for IVC blood provides suitable.Although equipment described herein has the special-purpose in postcava, the use at other positions of human body also can be predicted.And, although describe hepatic venous effluence, the flowing reversed by reclaiming catheter device can be carried out and carry a kind of medicine or multi-medicament or other materials to liver in the mode of driving in the wrong direction by hepatic vein or its hetero-organization.

Although funnel conduit and xegregating unit and use mesh knitted thing as the support of ad hoc structure and expandable component by returning above description describes of tube chamber, other option contained by present patent application, such as crosslinked spiral support structure, support shape structure, almost parallel line or support member, nonparallel line or supporting construction, contraction structure, circumferential gas cell, part-circular periphery air bag, spiral air bag, abutment structure and other.

When Therapeutic cancer, tumor, infect or relate to may only have one or two or several vein flow out the disease of other organs of this organ, inaccessible venacaval needs may do not had.The venous blood that the ostium venosum cordis that simple insertion funnel conduit directly enters this certain organs can be used as collection and isolate from this organ.Compared with the conduit based on air bag, funnel conduit (no matter being built by mesh knitted thing or other materials) is isolation and collects the simpler, more convenient, safer, more stable of Venous flow effluent and method faster, and covers clearly in the present patent application by any obturation of vein for collecting and isolate Venous flow effluent of funnel conduit.

In fact, with certain density any material perfusion topographic region that can cause toxic effect in other regions of human body, it is no matter the region of acra, abdominal part, breast, neck or brain, or other soft tissues or bone region, with not using air bag or providing material described in the inflatable systematic collection by pipeline to be the part of the application.Such as, described material can be the antibiotic for the treatment of local infection, antitumor drug, dissolve the thrombolytic agent of grumeleuse, transformation susceptible speckle is with stabilize plaque or dissolve speckle, stimulating cellular growth, delay Growth of Cells subtracts, eases the pain, causes Telatrophy or apoptosis, causes fat to decompose, cause hair growth or come off, improve or change audition, vision, the sense of taste, the material of olfactory sensation and sense of touch etc.Such as, the region of concentrating or organ are brain, salivary gland, thyroid, lymph node, soft tissue, lung, heart, spinal column, bone, kidney, utero-ovarian, breast, extremity, digestive tract, nasal region and nasal sinuses, eye, ear and larynx.

With highly enriched material to the regional perfusion of tumor region future be used for the treatment of in concentrated malignant tumor may really be first-line treatment to shrink tumor, if can not tumor be removed.If really there is any tumor to stay, then can perform the operation in less tumor.

Only there is the organ of one or two veins, or when the vein outflow of organ can be realized by the several conduits directly placed in said opening, the design of the funnel conduit 113 shown in Figure 16 can utilized.Another design of funnel conduit shows in figure 13a.The material of high enrichment can pour into the tremulous pulse entering described organ, and described funnel conduit is used for the recovery of described Venous flow effluent.Described Venous flow effluent can be pumped through described filter and be back to systemic circulation as previously discussed.The effect of the funnel in this particular can be controlled as the inside and outside actuator sleeve pipe 61 and 62 in Figure 10 A and 10B by mobile.The end of two actuator sleeve pipes 61,62 is angled in Figure 10 A and 10B, causes described funnel in the figure outstanding to side.Actuator sleeve pipe have not angled end time, described funnel to be kept straight on from the end of described two actuator sleeve pipes with shape shown Figure 13 A and 16 stretch to front.This can allow in the opening of the organ be treated, place described funnel conduit.Due to the mechanism by funnel as described in causing as the actuator sleeve pipe of two in Figure 10 A and 10B, the described funnel wall of vein that can align in mouth inside applies radial force and described fabric can be anchored on described intravenous funnel further.

The organ that can be suitable for this method comprises kidney, pelvic organ, extremity, brain, lung, breast and the various abdomen organs etc. by placing funnel conduit in portal vein.Can to for should organ arterial cannulation and inject described material.Using air bag to collect venous blood at end obtains fairly good with conduit work that the is inaccessible or problem of blocking-up vein, but does not stablize as designed, mainly because its spherical shape.Air bag tends to slide at Ink vessel transfusing, and has the inaccessible collecting duct of larger air bag to skid off the probability of the ostium venosum cordis at funnel conduit place as above.Described mesh knitted thing creates opposing and slides along wall of vein but do not damage the slight irregular surface of inner membrance on funnel.

And, because described in another reason, the shape of funnel is favourable.General balloon catheter has opening on the end of straight cylindrical conduit being just in time positioned at described air bag far-end.Described Venous flow effluent must be extracted by this end aperture, and because it is desirable for keeping the pressure in draining vein to be less than its pressure flowing into vein, can be aspirated to obtain the suction in described recovery conduit by pump.There is single end aperture, had suction not only to obtain turbulent flow and caused the probability of haemolysis, also have because suction causes the probability of the inaccessible single end aperture of wall of vein.Described funnel conduit overcomes these problems, and it enters the stable transformation of much smaller conduit from major diameter vein by providing, and minimizes turbulent flow and haemolysis and gets rid of the obturation of the described conduit due to suction.Extraly, retrieving in the Venous flow effluent of these single vein organs, it is necessary for minimizing or fully eliminate by any discharge of Collateral vein.There is many veins collateral, but when for a certain reason or other reasons in described organ, have a venous pressure of increase time just flow.Therefore, have the conduit that the suction that can maintain is forced down with the vein remained in described outflow vein and organ, collateral to flow around described recovery system and be leaked in systemic circulation be important preventing.

Certainly, the effectiveness round the sealing of the retracting device as xegregating unit is most important to prevent the harmful substance of high concentration from entering systemic circulation.Because hepatic vein pressure only has 1-5mmHg freely, be greater than the pressure in top IVC or right atrium, sealing need not with come by the pressure differential of 100-200mmHg that occluded artery flows identical.But the leakage not entering IVC from hepatic venous effluence room is necessary.The effectiveness testing described sealing may require to inject contrast agent continually, and this is time-consuming and not very accurately.The alternative approach detecting the leakage of any toxicant can be developed the real time measure of toxicant and periodically test systemic blood.Alternatively, material and the described toxicant that can inject easily mensuration enter Hepatic artery.Then, collecting with toxicant at hepatic venous effluence and be transported to outside, wherein different filters (arranged side by side with the filter of filter toxic material) or identical filter can filter out from by the blood being back to human body the material easily measured.Therefore, the sealing whether normal operation around described xegregating unit can be determined to the mensuration of the easy mensuration material of systemic blood.From returning blood the material filtering out and easily measure, if so there is any activity in systemic circulation, so it can remind the doctor in charge that toxic content leaks enters the high likelihood of systemic circulation.The material of easy mensuration can have metahemoglobin and carbon monoxide, or the characteristic of any other material (have simply it, fast and be easy to measure and be also the material easily filtered).

It is evident that the material comprising described device must have flexible, inflatable, collapsible etc. characteristic, it comprise adapt to difformity in same patient and size have enough annular power to realize the ability sealed completely.The various shapes run in IVC are than having circular and in consistent (but having gradually thin diameter minimum occasionally by the region that is treated or operates) general tremulous pulse being usually more changeable.Although the pressure of sealing needed for HVECC is less than Arterial system certainly, the needs that device adapts to different size and shape in same patient are very important building in for the device in IVC after liver.The structure of different embodiments of the present invention can utilize specifically adapt to vein and use design, material and technology, and be different from those devices usually utilized in the artery.

Compared with the xegregating unit of prior art, retracting device 138 can realize less to take up room and larger by returning tube chamber.Some embodiments with length-adjustable retracting device 138 can be manufactured, or the device without length can be used.

Any and all patents mentioned above, patent application and printed publication are incorporated to the application by reference.

When not departing from the present subject matter defined in following claim, disclosed embodiment and embodiment can be made an amendment and change.Such as, above embodiment and embodiment use different mechanical actuator with the blocking element of expanding proximal and far-end, single mechanical actuator can be used in some cases to identical effect, and such mechanical actuator can be contained in the air bag had in the retracting device of near-end and the far-end amplified when expanding.

Claims (14)

1., for the fluid being entered body passages by opening being guided to the method for fluid recycling apparatus, described method comprises:

With radial direction, inflatable and collapsible retracting device is placed in the mode of the first radial collapse configuration, and described retracting device is positioned at the opening part in body passages, described retracting device has proximal end and distal tip;

Described retracting device is positioned over the second expanded radially configuration, this placement step is undertaken by least one mechanical actuator element of mechanically actuated at least in part, mechanically expand described near-end and far-end blocking part thus, to make when described retracting device is placed in the second expanded radially configuration, described near-end and far-end blocking part have the radial dimension being greater than described middle body radial dimension, thus limit collecting chamber at least in part at described middle body; With

Fluid is made to flow into described retracting device from described collecting chamber.

2. the process of claim 1 wherein that using the first and second mechanical actuator elements of the near-end and distal tip that are operationally coupled to described retracting device to carry out described expanded radially configuration places step.

3. the method for claim 1 or 2, wherein carries out described expanded radially configuration by least one actuator element of mechanically actuated completely and places step.

4. the process of claim 1 wherein that described expanded radially configuration is placed step and also comprised inflation and block air bag at the near-end of described retracting device and the near-end of distal tip and distal annular rim.

5. the method for any one of claim 1-4, wherein said fluid flow step comprises the side passageway that allows fluid flow in described retracting device middle body and enters the recovery conduit extending into described retracting device.

6. the method for any one of claim 1-5, also comprise one of the near-end and distal tip that allow fluid to flow through described retracting device from described body passages, return tube chamber by being limited in described retracting device, and got back in body passages by another in the near-end of described retracting device and distal tip.

7. reclaim the method for Venous flow effluent from organ, described organ has distal vein and draining vein, and described method comprises:

The funnel device reclaiming catheter kit is placed on the vein opening part in the tubular body pipe of wanted treating organs, described funnel device has open end;

The open end of described funnel device is placed on the opening part in the distal vein of described organ;

Described funnel device is pressed in make to form sealing between described funnel device and described draining vein on described wall of vein, thus produces the collecting chamber be limited between described funnel device and described organ;

Perfusion medicament enters described patient;

By the fluid collection from described organ in collecting chamber;

Fluid collected by filtration; With

The fluid of filtered collection is back to described patient.

8. the method for claim 7, wherein said pressing step comprises and abuts against described funnel device expansion element.

9. the method for claim 7 or 8, the organ wherein carrying out described placement step is liver.

10. the method for any one of claim 7-9, wherein carries out described filtration step in described patient outside.

The method of 11. any one of claim 7-10, wherein said fluid collection collection step comprises the fluid of blood and described medicament, and described filtration step filters out described medicament.

12. are reclaiming the retracting device of catheter kit for determining and are collecting the method being sealed with validity at the collecting chamber place formed between the organ of fluid, and described method comprises:

Indicator and therapeutic agent is injected to patient;

The fluid being entered body passages by the opening of organ is collected in the collecting chamber limited between the fluid recycling apparatus reclaiming catheter kit and described organ;

Fluid collected by process, the treating step comprises and remove described indicator and described therapeutic agent from collected fluid;

Treated fluid is returned described patient;

Systemic fluid is collected from described patient; With

Described indicator whether is there is in systemic fluid collected by test.

13. for removing the method for therapeutic agent from patient, and described method comprises:

Therapeutic agent is injected patient;

Collect the fluid by organ;

The bond material comprising affinity agent is added in collected fluid;

Therapeutic agent in collected fluid is combined with described affinity agent;

Fluid collected by process and described bond material, the treating step comprises the described bond material removing from collected fluid and combine described therapeutic agent; With

Treated fluid is returned described patient.

The method of 14. claim 13, wherein said fluid collection step is included in the collecting chamber limited between fluid recycling apparatus and described organ reclaiming catheter kit and collects the fluid being entered body passages by the opening of organ.